Partnering with Pharmaceutical Leaders Active in Clinical Research

Partnering with Pharmaceutical Leaders Active in Clinical Research

Company Overview

DO IT RIGHT THE FIRST TIME!

• Berlin-based CRO

• Founded in 2004

• Founding member of MEDIS RESEARCH GROUP

• Audited member of BVMA e.V. (in association with EUCROF) since 2009

• Specialist for study management and monitoring

• Client base: international and regional biotechs, large pharma

• Full-service in setting up and conducting clinical trials with our

collaboration partners

www.allied-clinical.com 2

Academic Sourcing


• Close relationship with academic institutions training

clinical research professionals

(Beuth Hochschule, Parexel Academy, Mibeg Institute)

• Placements for practical training and thesis work

• Early recruitment of top-of-their-class future professionals

• Capacity for sudden increase of employees

• High staff retention due to strong relationsships with employees


Company History



• 2004 founding Michael Roehl founds Allied Clinical Management.

• 2006 restructuring Jörg Korb (formerly Charité) joins Allied Clinical

Management. Company restructures itself as a GmbH.

• 2008 first full study first full service study in indication ophthalmology

performed.

• 2009 BVMA ACM joins BVMA.

• 2010 first med device first full service medical device study in indication

cardio-vascular disease performed.

• 2013 ACM and ICRC-Weyer (Germany) collaborate as the

MEDIS RESEARCH GROUP to provide full CRO service.

Company Organisation



General Management

Office Management IT Support Quality

Management

MonitoringStudy

Documen-tation

Regulatory Devices

Ethic Submissions

Pharmaco-vigilance

Data Management

Medical Writing

Statistical Analysis

Proofreading and

Translation

Study Management

In-House External

Quality


• SOPs for all processes

• Document management

• Regular, documented GCP-Training for all employees

• Regular system audits by an independent auditor every 18 months

• Experience with CAPA-Processes and risk-based monitoring

• ACM is an audited member of the German Federal Association of Medical

CROs (in association with the European CRO Federation) since 2009


Quality Management: Computer Security


• Access-restricted and fire-protected facility

• Back-up IT-Systems

• Mirrored servers in separate locations

• Protected and access-controlled servers

• Firewall + virus protection

• Level-based access rights


Our Services


• Study Management

• Study Monitoring

• Study Documentation

• Regulatory Services

• Proofreading and translation→services can be contracted à la carte

• Full Service as MEDIS RESEARCH GROUP


Study Management


• Oversight of study conduct and study monitoring

• Budget management and tracking

• Primary contact for the sponsor

• Coordination of the study team

• Oversight of quality and timelines

• Risk assessment

• Vendor management

• Study set-up


Study Management


• TMF set-up and maintenance

• Consulting on (e)CRF selection and design

• Site feasibility and site selection

• Organization / leading of investigator meetings

• Creation of study documents and study specific operation guides

• On-site sfety (AE / SAE / medical incidents) management

• Drug supply and destruction

• Clinical study report and review


Study Monitoring


• Full monitoring-service, on-site and remote

• Risk-based monitoring

• Site visits (selection, initiation, interim, close-out)

• Source data verification

• Check of study lists and documents

• ISF set-up and maintenance

• Training of site staff


Study Monitoring


• Monitoring compliance with ICH-GCP, study protocol and regulatory

requirements

• AE / SAE management

• Conduct of interim analysis

• Query management

• Investigational product accounting

• Monitoring reports and follow-up letters


Study Documentation


• TMF set-up and maintenace

• ISF set-up and maintenance

• Consultation on (e)CRF selection and design

• Design of study documents (logs, worksheets, manuals, guidelines,

• tracking lists etc.)


Regulatory Services


• Clinical trial applications

• Marketing applications

• Medical device applications

• Collection of relevant documents

• Submission package for study initiation

• Submission of updated documents and changes

• Completion of checklists

• Correspondence with regulatory authorities and ethics committees

• Regulatory advice

• Quality reviewwww.allied-clinical.com 14

Proofreading and Translation


• Proofreading and translation of study protocols, patient diaries,

patient information and informed consent and other key clinical texts

• Native English and German speakers


Full Service


MEDIS RESEARCH GROUP offers its clients full CRO services

In addition to ACM services it offers:

• Biostatistics

• Data Management

• Medical Writing

• Pharmacovigilance

• Scientific Consulting


Experience with Remote Data Capture + Management Systems


• Medidata RAVE system

• RDC Oracle system

• Initiator eCRF system

• Science and technology on efficient information systems

and study planning tools (IMPACT, Cognos clinical trial planning system etc.)

and other clinical trial management systems

• Cost tracking tools


Experience: Study Types



Experience: Therapeutic Areas



Countries



ACM has monitored and performed oversight visits in the following countries:

● Austria ● Israel

● Czech Republic ● Latvia

● France ● Netherlands

● Germany ● Poland

● Great Britain ● Spain

● Hungary ● Switzerland

● Italy

Sponsors and Partners



Sponsors

● Bayer Health Care ● GALENpharma

● Bayer Pharma AG ● Miltenyi Biotec GmbH

● BioMS Medical Corp ● Novartis

● Biotie Therapies ● Pluristem Ltd.

● Elbion AG ● Weleda AG

Partners

● ICRC-Weyer (Germany)

Contact



Allied Clinical Management GmbH MEDIS RESEARCH GROUP

Berlin office: [email protected]ße 41 www.medis-research.com 10115 BerlinTel: +49 30 - 240 47 88 0 +49 30 - 240 47 88 22Fax:+49 30 - 240 47 88 29 [email protected]

www.allied-clinical.com

Partnering with Pharmaceutical Leaders Active in Clinical Research

Documents

service study

study managementdo

study monitoringdo

oversight of study conduct

study specific operation

service medical device

allied clinical management

quality management